18 results · 21ms · Sources: EU EUDAMED, US FDA

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ACE PROXIMAL HUMERAL NAIL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496033806·PERSONALITY 140 SHEER, SIZE 1XXL, GLACE, GRADUA...

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033806·Baltic Denture System BDLoad BDLoad Mw7 PLSEbi...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0330060·Rod Bender, 5.5 mm, 3 Position

SYNTHES METALLIC SPIKED WASHERS

FDA 510(k)
FDA Class 2 ·Orthopedic

URETEROSCOPES

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Injury ·KYPHON, INC.·Product code NDN·June 23, 2006

BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 17, 2022

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Injury ·KYPHON, INC.·Product code NDN·June 20, 2006

PORTASCAN

FDA Adverse Event
Malfunction ·MEDIWATCH UK LTD·Product code ITX·November 17, 2011

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 3, 2013

PARADYM

FDA Adverse Event
Malfunction ·SORIN CRM S.R.L.·Product code MRM·February 11, 2011

PROLIFT PELVIC FLOOR REPAIR

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·April 24, 2008

BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 2, 2023

Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.

FDA Recall
Terminated ·Smiths Medical ASD, Inc.·Product code BTO·April 19, 2005

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024